Outsourced Pharma, Contract Pharmaceutical, CRO, CMO, Pharmaceutical Drug Development Services

FEATURED EDITORIAL

A Woman Relegated To The Manufacturing Night Shift

After graduating with a biology degree from Howard University and entering the pharma industry, Stephanie Wimberly found herself the only woman — the only black woman — in a manufacturing facility in Maryland. A supervisor made it clear he didn’t want her on his team; she was reassigned to the night shift at her facility. “I had a family to support, and night shift, or abuse, was not what I signed up for,” she says. “But I didn’t have many options.” Here is how she persevered, and prospered.

GUEST COLUMNISTS

Green Supply Chains Rarely Start With A Pledge; Target Waste Instead
Effective sustainability strategies in pharma supply chains reduce rework and overage. Three leakage points offer the most practical starting point for rooting out waste.
The Real Reason We Haven't Fully Automated Cell Therapy Yet
Manual cell therapy workflows often set the tone for automation. This discussion suggests the approach is flawed and presents automation as a chance to innovate.
The Firefighting Era Of Clinical Supply Chain Is Over. Here's What Replaces It
Clinical trial supply chains are evolving: digital twins, on-demand kits, and sustainable logistics replace reactive firefighting with precision, speed, and resilience.
The Hidden Engineering Behind Successful Upstream Bioprocessing
In upstream biopharmaceutical production, manufacturing is inseparable from biology, engineering, contamination control, and quality science.
A Practical Look At Modern Downstream Processing For Biologics
Part 2 in a series about current bioprocessing practices explores the latest in separation, purification, sterile filtration and aseptic filling.
Process Engineering's Key Role In Sterile Injectable Facility Design
Quality requirements for parenteral drugs complicate facility design like few other regulated products. If you're developing injectables, be aware of these key issues.
What To Know About — And How To Apply For — FDA's PreCheck Pilot
FDA has now provided specific eligibility and selection criteria for the PreCheck Pilot Program and a timeline for next steps.
MES Is Still In The CD ROM Era But The Data Architecture Has Moved On
Many manufacturing execution system (MES) deployments still operate like it is 2005: a big install, disruptive upgrades, etc. Here's a clearer path forward.

PHARMA OUTSOURCING WHITE PAPERS

Key Selection Criteria For Cell & Gene Therapy CDMOs
Choosing the right CDMO requires early internal assessment plus strong technical capability, agility, advocacy, clear communication, and long‑term alignment to meet evolving cell and gene therapy needs.

Three-Dimensional Linkage Analysis With Digital PCR For Genome Integrity
A cost-effective approach with a comprehensive AAV analytical package holds the potential to advance the application of rAAV in cell and gene therapy for the treatment of human diseases.
A Risk-Based Approach To Plasmid DNA And mRNA Process Development
Balancing robust analytics and clinical readiness is key for early-phase pDNA and mRNA therapeutics amid structural complexity and regulatory challenges.
Open-Label Study Assessing Relative And Absolute Bioavailability
Consistent absorption across different formulations and dietary conditions ensures stable therapeutic exposure. This flexibility simplifies patient dosing schedules and supports manufacturing transitions.
Sustainability In Small Molecule API Manufacturing
Redesigning chemical processes with green chemistry principles can cut emissions, reduce waste, and improve efficiency. See how smarter synthesis and digital tools enable sustainable API manufacturing.
Calcium Carbonate Vs Titanium Dioxide: Why Particle Engineering Matter
Discover how particle-engineered calcium carbonate offers a viable alternative to titanium dioxide in tablet coatings, achieving good opacity, process efficiency, and comparable tablet properties.